The present invention relates generally to packages for medical catheters, and specifically to such a package having a tray portion and an insert portion, wherein the insert portion is releasably lockable in relation to the tray portion.
Conventional medical procedures include an extensive use of flexible catheters for diagnosis as well as various types of treatment. Typical catheters include tip portions having curved configurations designed for passage into and through body passageways such as blood vessels, heart passageways, intestinal lumens and in other regions, in many cases employing ultrasonic or fluoroscopic guidance. Opposite the tip portion is a hub or luer fitting for connection to other catheter manipulation and control devices. Surgeons and other medical personnel have come to rely upon catheter tip portions having specially designed shapes, and it is critical that during packaging and shipment, these shapes be maintained in their initially manufactured and sterilized form.
Another design criterion for catheter packages is that catheter tips are particularly prone to disfigurement during the removal of the catheter from the package. Accordingly, catheter package design efforts have been focused on preventing damage to the catheter tip, either during insertion into, storage within, or removal from the package.
A widely used form of catheter package includes an elongate catheter tray which supports the entire length of the catheter in an immobilized condition, and includes an insert which is slidable relative to the tray. The insert has a recess formed to enclose and protect the curved catheter tip.
The combined tray, insert and catheter combination is placed in a sealed flexible pouch to maintain sterile conditions. To remove the catheter from the package, the pouch is opened and the rear or access end of the catheter is pulled relative to the tray, which causes the insert and the catheter tip to move toward the access end of the tray. At a certain point, the insert separates from the tray, allowing the removal of the catheter tip. Often, such tray packages include ramps or other integral formations for facilitating the separation of the insert from the tray portion upon opening of the package.
A disadvantage of conventional catheter trays is that the tray portion, which is often produced by thermoforming sheets of polymeric material, is provided with side edge rails having undercuts defining a track in which the insert slides. These tracks are used both to retain the insert in position during shipment to avoid damaging the catheter tip, and also provide a guide for the withdrawal of the insert when the package is opened. However, it has been found that this type of undercut side edge configuration is difficult to accurately and efficiently die cut.
Another concern of users of conventional catheter tray packages is that the insert be immobilized on the tray during shipment, and until the package is opened. Tray packages employing undercut side edges also must be provided with some sort of locking or friction fit formation to secure the insert in position. These additional locking formations, whether found on the tray or on the insert, create problems in tool design and package formation techniques.
Accordingly, it is an object of the present invention to provide a catheter tray package having an insert tray retaining and guide configuration which is effective in releasably locking the insert in position relative to the tray portion without the use of undercut formations.
It is another object of the present invention to provide a catheter tray package with an insert locking configuration which easily releases upon the pulling of the luer end of the catheter by medical personnel when the package is opened.
Still another object of the present invention is to provide a catheter tray package in which the locking formation also is configured to facilitate the separation of the insert portion from the tray portion upon the opening of the package.